
Reputation and Power : Organizational Image and Pharmaceutical Regulation at the FDA.
Title:
Reputation and Power : Organizational Image and Pharmaceutical Regulation at the FDA.
Author:
Carpenter, Daniel.
ISBN:
9781400835119
Personal Author:
Physical Description:
1 online resource (866 pages)
Series:
Princeton Studies in American Politics: Historical, International, and Comparative Perspectives
Contents:
Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA -- CONTENTS -- LIST OF ILLUSTRATIONS -- LIST OF TABLES -- ACKNOWLEDGMENTS -- LIST OF ABBREVIATIONS AND ACRONYMS -- INTRODUCTION The Gatekeeper -- CHAPTER ONE Reputation and Regulatory Power -- PART ONE: ORGANIZATIONAL EMPOWERMENT AND CHALLENGE -- CHAPTER TWO Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath -- CHAPTER THREE The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961 -- CHAPTER FOUR Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966 -- CHAPTER FIVE Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986 -- CHAPTER SIX Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992 -- PART TWO: PHARMACEUTICAL REGULATION AND ITS AUDIENCES -- CHAPTER SEVEN Reputation and the Organizational Politics of New Drug Review -- CHAPTER EIGHT The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite -- CHAPTER NINE The Other Side of the Gate: Reputation, Power, and Post-Market Regulation -- CHAPTER TEN The Détente of Firm and Regulator -- CHAPTER ELEVEN American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies -- CHAPTER TWELVE Conclusion: A Reputation in Relief -- PRIMARY SOURCES AND ARCHIVAL COLLECTIONS -- INDEX -- Illustrations -- 2.1. Change in Probability of Pro- Regulatory Vote for Every Additional UMMA Firm Headquartered in Senator's State -- 2.2. An Elixir Sulfanilamide Label, 1937 -- 2.3. Distribution of Massengill's Elixir Sulfanilamide (USDA Report to Congress, 1937) -- 2.4. The Joan Nidiffer Photo, in Report of the Secretary of Agriculture, 1937.
3.1. Edwin Goldenthal's Halting of the NDA for Trancopal, April 1958 -- 3.2. The Published New Drug Application Form of 1956 -- 3.3. FDA Food versus Drug Enforcement, 1947-1954 -- 3.4. Quantiles of the Approval Time Distribution for New Molecular Entities, 1950-1964 (by year of submission) -- 3.5. FDA Approval Hazard Ratios for NMEs under Three Successive Regimes, 1950-1968 -- 4.1. Thalidomide Images from the National Enquirer -- 4.2. The Washington Post Thalidomide Story of July 15, 1962 -- 4.3. Major Newspaper Articles Mentioning "Thalidomide" -- 4.4. Kennedy Awards the Distinguished Civilian Service Medal to Frances O. Kelsey, 1962 -- 5.1. Number of Major Newspaper Articles Mentioning "Thalidomide" and Number Mentioning FDA and "Protect," 1960-1985 -- 6.1. NCI- FDA Memorandum of Understanding (January 1979) -- 7.1. Bureau of Drugs Organizational Chart -- 7.2. Percentage of NME Applications "Rejected" or Withdrawn, 1976-1998 -- 7.3. Relative Speed of Approval by Therapeutic Category, Approved NMEs Submitted 1962-1985 -- 7.4. Expected Duration of Approval by Therapeutic Category, NMEs Submitted 1986-2004 -- 7.5. Change in NME Review Time (months) for Every Standardized Increase in Media Coverage of NME's Primary Indication Disease, 1976-1998 -- 7.6. Change in Probability of Pre- Market Advisory Committee Consultation for Every Standardized Increase in Media Coverage of NME's Primary Indication Disease, 1992-2004 -- 7.7. Average Approval Times by Order of Entry, 1962-2000 -- 7.8. Paragraphs from William Gyarfas' October 24, 1978 Recommendation for Approval of Cisplatin (Platinol) for Testicular and Ovarian Cancer -- 7.9. Percentage of NME Approvals in December, 1970-2000 -- 8.1. Additional Drug Projects Abandoned for Every Standardized Shock in Sponsor Firms' Asset Price Induced by FDA Rejection or Delay.
9.1. Change in Probability of Black- Box Label Warning when Average Tenure of Approving Division Moves from Minimum to Mean -- 10.1. Change in Probability of Non- Approvable Letter Associated with One- Standard- Deviation Increase in Sponsor's Previous INDs -- 10.2. Average NMEs Approval Time by Sponsor's Previous NMEs -- Tables -- I.1. Features of U.S. Pharmaceutical Regulation Adopted in Other Nations -- 2.1. Subject Headings in the USDA's Report on Elixir Sulfanilamide (November 1937) -- 2.2. Comparison of S.5 before and after Sulfanilamide Tragedy and Wallace Proposal -- 3.1. Selected Members of the Post-War Cohort at the U.S. Food and Drug Administration, 1947-1963 -- 3.2. Variants of Coal-Tar Dyes Permitted in Marketing, by Country, 1954 -- 4.1. Partial Summary of Changes Effected by Kefauver-Harris Amendments of 1962 -- 4.2. References to Phased Clinical Studies in Western Medical Literature, 1950-1980 -- 5.1. Membership of the HEW Advisory Committee on the FDA, September 1960 -- 5.2. Membership of the Advisory Committee on Investigational Drugs, January 1965 -- 5.3. Membership of the Medical Advisory Board (FDA Bureau of Medicine), 1969 -- 5.4. Committee Memberships Formally Managed by the FDA, 1967 -- 5.5. FDA Public Advisory Committees, 1967 -- 5.6. List of Congressional Hearings on Pharmaceutical Regulation at FDA, 1960-1980 -- 5.7. Frequency of Agency Mentions in Major Newspaper Articles, 1960-2007 -- 7.1. Medical Officers in the Investigational Drug Branch, Bureau of Medicine, U.S. Food and Drug Administration, 1964 -- 7.2. Ten Possible Outcomes in Treatment -- 7.3. Disease-Specific Entry-Order Gradients, Expressed as Elasticities -- 9.1. Searle's Experience with New Drug Approval before and after the 1968 Report -- 9.2. Drug Changes Requiring a Supplemental NDA, 1970-2006.
9.3. Required Label Sections from Uniform Labeling Requirements from 1979 -- 10.1. Smith Kline and French Corporate Leadership after 1971 -- 10.2. Approval Probabilities (Expressed in Percentages), by Quantiles of Firm Sales Distribution NMEs Reviewed, 1977-2000 -- 10.3. Rank Ordering of Aggregate Advantage for Firms Sponsoring More than 1 Percent of Approved NMEs, 1977-2000 -- 10.4. Variables Associated with Probability of Receiving a Priority Rating, NMEs Submitted 1977-2000 -- 11.1. Cross-National Dependencies in Global Pharmaceutical Regulation in the Twentieth Century -- 12.1. "Rating the FDA".
Abstract:
The U.S. Food and Drug Administration is the most powerful regulatory agency in the world. How did the FDA become so influential? And how exactly does it wield its extraordinary power? Reputation and Power traces the history of FDA regulation of pharmaceuticals, revealing how the agency's organizational reputation has been the primary source of its power, yet also one of its ultimate constraints. Daniel Carpenter describes how the FDA cultivated a reputation for competence and vigilance throughout the last century, and how this organizational image has enabled the agency to regulate an industry as powerful as American pharmaceuticals while resisting efforts to curb its own authority. Carpenter explains how the FDA's reputation and power have played out among committees in Congress, and with drug companies, advocacy groups, the media, research hospitals and universities, and governments in Europe and India. He shows how FDA regulatory power has influenced the way that business, medicine, and science are conducted in the United States and worldwide. Along the way, Carpenter offers new insights into the therapeutic revolution of the 1940s and 1950s; the 1980s AIDS crisis; the advent of oral contraceptives and cancer chemotherapy; the rise of antiregulatory conservatism; and the FDA's waning influence in drug regulation today. Reputation and Power demonstrates how reputation shapes the power and behavior of government agencies, and sheds new light on how that power is used and contested. Some images inside the book are unavailable due to digital copyright restrictions.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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